On August 31, Hyman, Phelps & McNamara, P.C. (“HPM”) submitted comments to FDA’s June 1 Draft Guidance regarding research use only (“RUO”) products (see our previous posts here and here). Although HPM supports many parts of the Draft Guidance, in its comments, it objected to FDA statements indicating that the manufacturer must halt selling to a customer if the manufacturer knows or has reason to know that the customer is using the product for a clinical diagnostic use. HPM also expressed concerns with statements in the Draft Guidance that suggest that only certain types of research could qualify for RUO status.

HPM maintained that these statements in the Draft Guidance represent a departure from past agency regulations, case law and policy, would have sweeping implications for multiple categories of FDA-regulated products, and can only be issued through notice-and-comment rulemaking.

HPM stated that the manufacturer’s representations, not what the manufacturer knows or had reason to know, should determine the intended use of the product. The agency’s expansive and novel approach to intended use has broad implications for other regulated products, such as drugs, biologics, and devices. HPM argued that FDA should not require manufacturers to immediately halt selling RUO products based on customer behavior. HPM also called on the agency to clarify that all types of research qualify for the RUO exemption.

If FDA insists upon these aspects, according to the HPM comments, FDA should only do so through notice-and-comment rulemaking. HPM’s views that rulemaking is required is supported by a recent decision by a Florida district court rejecting FDA’s request for an injunction against a compounding pharmacy.

Over thirty comments were submitted, including comments from representatives of manufacturers, laboratories, and academic institutions. These comments criticized the proposal for: requiring manufacturers to police the activities of their customers; inappropriately expanding the concept of intended use; limiting patient access to standard-of-care laboratory-developed tests that had been appropriately validated in accordance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 ("CLIA"); impeding research and the development of new tests; interfering with the practice of medicine; and violating the Administrative Procedure Act. Virtually all comments criticized one or more of these aspects of the draft guidance.